MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ANTHOLOGY HIP IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number UNKN01101100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Kyle alpaugh, yu-fen chiu, jason p.Zlotnicki, ilya bendich, alejandro gonzalez della valle, mathias p.G.Bostrom, elizabeth b.Gausden,femoral component undersizing and alignment are risk factors for early periprosthetic femur fracture,the journal of arthroplasty, volume 37, issue 7, supplement, 2022, pages s604-s610, issn 0883-5403, https://doi.Org/10.1016/j.Arth.2022.03.015.

Event Description

It was reported that on literature review "femoral component undersizing and alignment are risk factors for early periprosthetic femur fracture", after undergoing a tha with an anthology cementless stem, two (2) patients sustained a periprosthetic femur fracture.Patients¿ outcome and how it was treated is unknown.No further information is available.

Event Description

It was reported that on literature review "femoral component undersizing and alignment are risk factors for early periprosthetic femur fracture", after undergoing a tha with an anthology cementless stem, two (2) patients sustained a periprosthetic femur fracture.Patients required revision surgery.Patients¿ outcome is unknown.No further information is available.

Manufacturer Narrative

B5 (describe event or problem), h6 (health effect - impact code).

• Brand Name: UNKN ANTHOLOGY HIP IMPL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18365676
• MDR Text Key: 331006920
• Report Number: 1020279-2023-02531
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKN01101100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other